0310-0610-28 |
0310-0610 |
HUMAN PRESCRIPTION DRUG |
KOSELUGO |
SELUMETINIB |
CAPSULE |
ORAL |
20210611 |
N/A |
NDA |
NDA213756 |
AstraZeneca Pharmaceuticals LP |
SELUMETINIB |
10 mg/1 |
28 CAPSULE in 1 BOTTLE (0310-0610-28) |
0310-0610-60 |
0310-0610 |
HUMAN PRESCRIPTION DRUG |
KOSELUGO |
SELUMETINIB |
CAPSULE |
ORAL |
20200416 |
N/A |
NDA |
NDA213756 |
AstraZeneca Pharmaceuticals LP |
SELUMETINIB |
10 mg/1 |
60 CAPSULE in 1 BOTTLE (0310-0610-60) |
0310-0625-28 |
0310-0625 |
HUMAN PRESCRIPTION DRUG |
KOSELUGO |
SELUMETINIB |
CAPSULE |
ORAL |
20210611 |
N/A |
NDA |
NDA213756 |
AstraZeneca Pharmaceuticals LP |
SELUMETINIB |
25 mg/1 |
28 CAPSULE in 1 BOTTLE (0310-0625-28) |
0310-0625-60 |
0310-0625 |
HUMAN PRESCRIPTION DRUG |
KOSELUGO |
SELUMETINIB |
CAPSULE |
ORAL |
20200416 |
N/A |
NDA |
NDA213756 |
AstraZeneca Pharmaceuticals LP |
SELUMETINIB |
25 mg/1 |
60 CAPSULE in 1 BOTTLE (0310-0625-60) |